Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

Completed

• Conditions: Retinal Detachment; Vitrectomy
• Interventions: Diagnostic Test: Microperimetry; Diagnostic Test: M-charts

• Registration Number: NCT03902795
• Lead Sponsor: Medical University of Lublin

Brief Summary

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Detailed Description

Background:

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

Methods:

The study included 62 eyes that underwent successful PPV with SF6 tamponade with macula-on (34 eyes) and macula-off (28 eyes) RRD preoperatively. The best-corrected visual acuity (BCVA), Amsler test, M-charts, optical coherence tomography (OCT) and microperimetry were performed at 1, 3 and 6 months postoperatively.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Study First Posted: 2019-04-04
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• The diagnosed macula-on and macula-off rhegmatogenous retinal detachment.

Exclusion Criteria

• history of uveitis,
• diabetic retinopathy,
• previous vitreoretinal surgery,
• glaucoma or eye trauma,
• retinal detachment combined with macular hole or proliferative vitreoretinopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group of 62 eyes	M-charts	Group of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade
Group of 62 eyes	Microperimetry	Group of 62 eyes with rhegmatogenous retinal detachment who underwent successful vitrectomy with SF6 tamponade

Primary Outcome Measures

Name	Time	Method
M-charts	1 to 6 months	The M-charts consist of 19 dashed lines with increasing distance between points in the range of 0.2 ° to 2.0 ° viewing angle. Matsumoto developed M-charts for quantitative metamorphopsia evaluation in macula diseases in 1990. M-charts provide more information than Amsler chart in regard to the horizontal and vertical lines.
The best-corrected visual acuity (BCVA)	1 to 6 months	Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable.
Amsler test	1 to 6 months	The standard Amsler test performs with black lines on the white background. The Amsler grid has been used so far for the qualitative assessment of the metamorphopsia since 1947.
Central retinal thickness	1 to 6 months	Quantitative thickness measurements derived from the "fast macular scan" algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula.
Microperimetry	1 to 6 months	Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.

Trial Locations

Locations (1)

General Department of Ophthalmology in Lublin; 🇵🇱 Lublin, Poland